Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Thursday, September 08, 2005

Here is a letter to the editor in response to an article in the Philadelphia Inquirer on abuses in academic biomedical research, and how this may put the rights of indigenous populations around the world at risk. The recently-announced Genographic Project has the tracing of human migration patterns as its ostensible purpose. The new project bears a remarkable resemblance to the highly controversial and failed Human Genome Diversity Project (HGDP) of the 1990's:

As you document in your article “A Familial Trail, the Genographic Project”, Philadelphia Inquirer, Sep. 5, 2005, DNA evidence is indeed revealing a history of human migration, filling in the details of human spread over the earth. This is a fascinating endeavor, although as I question later, perhaps this initiative is an indulgence whose resources might be better spent finding treatments for disease.

I also take this opportunity to amplify the fact that the Genographic project itself has a familial trail, a trail somewhat littered with controversial and unappealing debris. This project is following in the tarnished footsteps of the Human Genome Diversity Project (HGDP), which your article points out became known by the indigenous peoples that it purported to study as the “vampire” project. It received the mark of the fabled Transylvanian parasite, perhaps not without good reason.

You quote Yale geneticist Ken Kidd, Professor of Genetics, Psychiatry, and Molecular, Cellular & Developmental Biology at Yale, one of the HGDP project's founders, as stating that he “never fully understood what went wrong” with the HGDP.

Perhaps this statement reflects Dr. Kidd’s assumptions about intellectual capabilities of uneducated, often poor, indigenous peoples. Does he or other scientists believe them stupid or naïve? These indigenous people, while undoubtedly not educated to the level of a Dr. Kidd, are also unspoiled by the privileges of status, power, and the other accoutrements of wealth and Ivy League tenure. They have survived as indigenous people through their wits. Their instincts are pure and untainted by Western decadence. They are, first and foremost, excellent judges of people and people’s intentions, because they’ve had to be, in order to survive under often harsh natural and increasingly man-made conditions.

Let me remind Dr. Kidd just what “went wrong.” The HGDP was very strongly opposed by a number of indigenous populations around the world. Despite promises to the contrary, the indigenous populations feared misappropriation of their genetic material and of commercial discoveries made from their blood and tissues. The Declaration of Indigenous Peoples of the Western Hemisphere Regarding the Human Genome Diversity Project, for example, as recorded at the website of the South and Meso American Indian Rights Center, states:

In the long history of destruction which has accompanied western colonization we have come to realize that the agenda of the non-indigenous forces has been to appropriate and manipulate the natural order for the purposes of profit, power and control. To negate the complexity of any life form by isolating and reducing it to it's minute parts, western science and technologies diminishes its identity as a precious and unique life form, and alters its relationship to the natural order. Genetic technologies which manipulate and change the fundamental core and identity of any life form is an absolute violation of these principles, and creates the potential for unpredictable and therefore dangerous consequences.[1]

As observed by Silvia Ribeiro of the Action Group on Erosion, Technology and Concentration (ETC Group), the Human Genome Diversity Project was a project of various universities begun in the early 1990s, intended to search for the genetic differences – called Single Nucleotide Polymorphism (SNP) – in 722 communities throughout the world, many of them indigenous groups defined as “in danger of extinction.” The HGDP tried to “conserve the genetic material for research” before these groups disappeared. Not conserve the people, just their genetic material. The people sampled did not know toward what ends the samples were used, and the information was placed on the Internet and in repositories similar to that of the Coriell Institute, later giving rise to many patents over them, held by corporations and universities. Thanks to denunciations by RAFI (Rural Advancement Foundation International, now called ETC Group), together with the indigenous peoples of the world, the Vampire Project, as they called it, had to be watered down, but it has never accounted for the samples obtained.[2]

I should indicate at this point that I did work related to HGDP in the early-to-mid 1990’s, and when these statements were made, I too felt the indigenous populations might have been overreacting.

However, when my own intellectual property came under attack (a computer program called SAYGR designed to improve the care of Middle Eastern children with birth defects), my understanding of their feelings and identification with their judgments became crystal clear.

A tenured senior faculty person strongly involved in HGDP tried in a disingenuous manner to obtain documentation and source code to software I’d written as untenured junior Yale faculty. This senior faculty person attempted to obtain this material from a visiting foreign scientist.

The senior faculty person and a colleague of his, another senior tenured faculty member, desired my computer programs for their own research and sought to simply take it from me without negotiation. I had for a number of reasons denied my programs to them until legal agreements could be worked out for sharing potentially valuable code with them. Such agreements were under discussion with Yale’s Cooperative Research Office, as both of them were well aware after being informed both verbally and in writing.

Note: by Yale intellectual property policy, copyright ownership of faculty work, including software, explicitly remained with the faculty author:

Copyrightable works of authorship include, among other categories, books, articles and other written works; musical and dramatic works; pictures, films, videos, sculptures and other works of art; computer software; and electronic chip designs. It is traditional at Yale … for books, articles and other scholarly writings by a faculty member to be deemed the property of the writer, who is considered to be entitled to determine how the works are to be disseminated and to keep any income they produce.[3]

The University's existing copyright policy addresses ownership issues. Under existing policy the University disclaims, except in defined circumstances, any ownership of the copyrights in books, articles, and other scholarly works created by faculty, students and staff.[4]

Nonetheless, when a professor from Saudi Arabia with whom I had shared the documentation and computer code was visiting at Yale, I received these somewhat frantic emails from him regarding the senior faculty person's behavior. The emails speak for themselves (names are omitted):

----------------------------

Subj: I need helpDate: 96-06-12 14:24:09 EDTFrom: [name withheld]

I hope you will find this message in the next 30 minutes and you will reply.

I have a meeting with [senior faculty person involved in HGDP] at 3:00 pm and he wants me to give him the SAYGR manual (I told him that I do not have a hard copy, and I will look at my disks at home to see if I have a soft copy) and he wants to see whether my version of SAYGR is the same as his and if it is he wants my version. I will erase all version indications so he would not know what version it is. He says his version has a bug in the pedigree template? and is difficult for him to use.

I did not want to let him know that I know what is being going on. What do you want me to do if he insists getting a copy of my SAYGR? I hope he does not. If you do not respond I will try my best to make it look like our versions are identical so he would not want what I have. He has not said anything about any legalities that he is involved with SAYGR so I pretend not to know anything. I do not want to put you or myself in a compromizing position and let him know that we are friends and we talk. I will for sure not give him the manual and I will do the impossible not to give him the program.

I will let you know what happened.

It should be interesting.

M.

----------------------------

Subj: READ, READDate: 96-06-12 16:39:23 EDTFrom: [name withheld]

I just got out from my meeting with [senior faculty person involved in HGDP]. He insist in getting my copy of SAYGR because he knows you were making some improvements for me. He also insists in getting the manual. I managed the manual issue by saying that I do not have it with me. I have a lot of interesting information that we need to discuss. Do you have the version that you gave [other local colleague] so I can give that to [senior faculty person involved in HGDP] instead of mine? He did not mention anything about being in dispute with you on the rights to use it. Please advice as soon as you can.

He has his own copy and [other local colleague] has one too. They had a problem figuring out which is the most updated and he felt that mine probably was and that is why he wanted it.

Let me know what you want me to do

I will stay here late in case you try to get in touch with me.

M.

----------------------------

The embarrassment and insult suffered by the visitor, who was put on the spot in a most unpleasant manner, led to him reporting these events to his boss back in Saudi. The senior faculty person attempting to misappropriate my IP apparently lost access to Saudi blood samples he was promised as a result.

One lesson I learned is that the fears of the indigenous peoples towards Genome projects that sample their blood are not inappropriate, considering how one person involved in the project apparently regarded his own junior and foreign colleagues and property rights. Ironically, of all people, Human Genome Diversity personnel had an obligation to conduct themselves in a manner beyond reproach.

These issues bring up a series of questions that must be asked prior to the initiation of new international studies of indigenous genomes:

(1). Should academia alone be entrusted to collection and stewardship of indigenous populations’ genomic data and of the inventions discovered as a result of such possession?

Academics, especially those with tenure, are less accountable than even industry and governmental officials (as, for example, FDA’s and Merck’s current trials and tribulations illustrate). Of all people, genome information is perhaps least safe in the hands of academics. A significant portion the public in the U.S., let alone indigenous people, is not entirely trusting of the potential for misuse of clinical and genetic data.[5] At least in profit-driven industry those in possession of the data face the threat of litigation and financial ruin for misuse of such data.

Academia itself lacks a pristine reputation on handling of intellectual property matters. For example, several years ago bitter authorship disputes were found to be increasingly frequent by the Ombud of Harvard Medical School and felt to affect other academic institutions as well. Even worse, the Harvard Ombud wrote that “it is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures.”[6] In my response in JAMA I indicated alarm at the latter opinion.[7] If universities admittedly cannot protect their own, I ask, how can they possibly protect their research subjects’ interests when disputes arise?

(2) Does Ivy-League academia intrinsically respect the notion of individual or collective intellectual or genetic-information property? The Free software movement began in the "hacker" culture of U.S. computer science laboratories (Stanford, Berkeley, Carnegie Mellon) and is an academic concept designed to block corporations from capitalizing on the advantages of intellectual property ownership.[8] This movement considers free software a matter of “liberty” as in "free speech".[9] While trying to deny Bill Gates and Microsoft the benefits of intellectual property protection may not seem like a bad idea to some, and while free software such as the Linux operating system has enabled a lot of useful research, disrespect towards the property rights of indigenous populations via such widespread academic ideologies would be, quite frankly, a risk of a renewed Genome project under any name. It would be an atrocity if harm actually occurred.

(3) Has it ever been possible to hold academia accountable for anything in front of any authority? Some in academia make the most outlandish of statements or engage in questionable activities and rights abuses, often without significant loss of career or income. [10,11,12,13,14,15,16]

(4) Do academics respect minorities and act out of selfless nature, or do some in academia exploit minorities and act out of self-aggrandizement for their own egos? What does the widespread exploitation of graduate students, often foreign-born, say about academic ethics in this regard?[17]

Those good people in academia who respect others and honor social justice are often reluctant to speak out against abuses. I believe the caution of indigenous people in being subjects of genomics research, especially "vanity" projects such as the Genographic project is well-placed. I suggest that we need to have global, binding, enforceable agreements regarding the use of indigenous genomes and any inventions such data may generate. A world body such as the WHO or UN, via the UN Working Group on Indigenous Populations[18], should be engaged in formulating such agreements. This would avoid the “misunderstandings” quoted by Dr. Kidd, as well as minimize the risks of exploitation of indigenous populations that such an initiative raises by those faculty more interested in their own careers than in social justice.

I also suggest we look at the possibility of devoting the resources of this Genographic study (considering that its parental Human Genome Diversity Project was delayed for years and then cancelled without major repercussions) to areas of research endeavor more likely produce actual treatments of value to patients. It is well documented that the promises of genetic medicine are far from realized. Although the combined effort of publicly funded genome projects and private investments resulted in rapid identification of essentially all genes of the human genome, harnessing this information to enable drug discovery has turned out to be more challenging and time consuming than initially anticipated.[19]

Let’s make sure we as a society have our scientific priorities in order.

FOOTNOTES:

1. Declaration of Indigenous Peoples of the Western Hemisphere Regarding the Human Genome Diversity Project, South and Meso American Indian Rights Center (SAIIC), http://www.indians.org/welker/genome.htm

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